BEUDAMED
    Product Code: JYY FDA class 1 21 CFR 874.4420

    Rasp, Ear

    Ear, Nose, Throat

    Rasp, Ear is a surgical hand instrument with an abrasive surface used to smooth or reshape bony surfaces within the ear canal or mastoid cavity during otological surgery, providing accurate contouring of bone for optimal surgical outcomes. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JYY, regulated under 21 CFR 874.4420, and falls within the Ear, Nose, Throat medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    JYY
    Device Class
    FDA class 1
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Review Panel
    EN
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K822253 RASPS

    FEI Numbers

    This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.